AUBAGIO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TERIFLUNOMIDE

Available from:

SANOFI ISRAEL LTD

ATC code:

L04AA31

Pharmaceutical form:

FILM COATED TABLETS

Composition:

TERIFLUNOMIDE 14 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SANOFI WINTHROP INDUSTRIE, FRANCE

Therapeutic area:

TERIFLUNOMIDE

Therapeutic indications:

Aubagio ® is indicated for the treatment of adult patients with relapsing remitting forms of Multiple Sclerosis (MS) ) to reduce the frequency of clinical relapses and to delay the progression of physical disability.

Authorization date:

2019-01-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
AUBAGIO
Film-coated tablets
COMPOSITION
Each tablet contains:
The active ingredient and its quantity: Teriflunomide 14 mg
Each tablet also contains 76 mg lactose monohydrate.
Inactive ingredients and allergens: see section 2 (“
Important information about some of
the ingredients of the medicine
”) and section 6 ("Further Information").
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for you only, do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar.
The medicine is not intended for children and adolescents below the
age of 18 years.
In addition to the leaflet, Aubagio also has a Patient Safety
Information Card. This card
contains important safety information that you must know and abide by
before starting
treatment and during treatment with Aubagio.
Read the Patient Safety Information Card and the Patient Leaflet
before commencing
use of the preparation. Keep the card for further reading, if
necessary.
1. WHAT IS THE MEDICINE INTENDED FOR?
Aubagio contains the active ingredient teriflunomide, a substance that
acts on the immune
system to limit its attack on the nervous system.
Aubagio is intended for the treatment of adults with
relapsing-remitting multiple sclerosis,
in order to reduce the frequency of relapses and to delay the
progression of disability.
WHAT IS MULTIPLE SCLEROSIS
Multiple sclerosis (MS) is a chronic disease that affects the central
nervous system (CNS).
The CNS is made up of the brain and spinal cord.
In MS, the inflammation destroys the protective sheath (called
“myelin”) that surrounds
the nerve fibers of the CNS. Loss of myelin is called demyelination
and it disrupts the
normal activity of th

Summary of Product characteristics

Aubagio-tab-SPC-9.0
1
1.
NAME OF THE MEDICINAL PRODUCT
AUBAGIO 14 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 14 mg of teriflunomide.
Excipient with known effect: each tablet contains 76 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pale blue to pastel blue, pentagonal film-coated 7.5 mm tablet with
imprint on one side (‘14’) and
engraved with a corporate logo on the other side.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
AUBAGIO is indicated for the treatment of adult patients with
relapsing remitting forms of Multiple
Sclerosis (MS) to reduce the frequency of clinical relapses and to
delay the progression of physical
disability (please refer to section 5.1 for important information on
the population for which efficacy has
been established).
4.2 Posology and method of administration
The treatment should be initiated and supervised by a physician
experienced in the management of multiple
sclerosis.
Posology
The recommended dose of teriflunomide is 14 mg once daily.
Film-coated tablets can be taken with or without food.
Special populations
Elderly population
AUBAGIO should be used with caution in patients aged 65 years and over
due to insufficient data on safety
and efficacy.
Patient safety information Card
The marketing of AUBAGIO is subject to a risk management plan (RMP)
including a 'Patient safety
information card'.
The 'Patient safety information card', emphasizes important safety
information that the patient should
be aware of before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
Aubagio-tab-SPC-9.0
2
Renal impairment
No dose adjustment is necessary for patients with mild, moderate or
severe renal impairment not
undergoing dialysis.
Patients with severe renal impairment undergoing dialysis were not
evaluated. Teriflunomide is
contraindicated in this population (see section 4.3).
Hepatic impairment
No dose adju